apec harmonization center - apac-asia.com · 223 trainees from 11 apec travel eligible economies ....
TRANSCRIPT
APEC Harmonization Center
Contents
About AHC
The AHC activities
Background
Objective
Strategic Approach
Workshops
Research
Online Training
How to involve
About AHC
About AHC
Background
About AHC
Objective
Strategic Approach
The APEC Harmonization Center (AHC) was established to provide a platform to address and solve priority of APEC member economies on regulatory harmonization.
RHSC AHC
AHC Advisory
AHC Secretariat
(KPMA)
AHC Director (MFDS, NIFDS)
2008. 8. Korea proposed the establishment of the AHC at the 4th LSIF in Lima, Peru
2008.11. APEC Ministers specifically endorsed the AHC in the annual Ministerial Joint Statement
2009.6. Established at the MFDS, Korea (under the authority of APEC LSIF)
Objective
Objective
Background
About AHC
Strategic Approach
To facilitate regulatory convergence in the region and beyond
To support access to best practices and international guidelines
To promote collaborative actions and information
sharing
To enhance quality, safety and efficacy of medicinal products
Regulatory Convergence in the APEC Vision
Hosting Workshops
Strategic Approach
Objective
Background
About AHC
Strategic Approach
Face to Face Training Online Training
- AHC Workshop Videos and Presentation Materials - Research Papers
Research Projects on Pharmaceutical Regulatory
Framework (APEC)
Broadening AHC Activities Center of Excellence (CoE)
Cooperating Globally with APEC LSIF Regulatory Harmonization Steering Committee (RHSC)
and other international organizations
Research
The AHC Activities
Workshops
Workshops
The AHC Activities
Research
Online Training
AHC supports RHSC PWAs (Priority Work Areas) and devotes to regulatory convergence in the APEC.
Advanced Cell and Tissue
Therapy
Medical Product Quality and Supply
Chain Integrity
Good Registration Management
Multi-Regional Clinical Trials and
Good Clinical Practices
Biotherapeutics
Pharmacovigilance and Medical Device
Vigilance
1
2 AHC selects topics that are needed in regulatory convergence such as Generic Drugs and Medical Device.
Workshop The AHC Activities
The AHC Workshops (2009~2016.3.) 28 workshops, 8100 attendees 109 speakers from 25 countries 223 trainees from 11 APEC travel eligible economies
Achievements Regulatory gap analysis
Training on the basis of recommendations from gap assessment Training for regulators from APEC travel eligible economies
Future Plan– Center of Excellence (CoE) The RHSC agreed to explore the establishment of CoEs to ensure sustainable platform for promoting regulatory convergence The AHC takes role to coordinate CoEs
Workshops
Research
Online Training
Network
Workshop – 2016 plans The AHC Activities
Workshops
Research
Online Training 1
Medical Product Integrity and Supply Chain Security Workshop
Feb 20 - 24 (5 days), Lima, Peru
2 Biotherapeutics CoE Pilot
Late Jul, Northeastern University, United States
Medical Product Integrity and Supply Chain Security Workshop
Aug, Lima, Peru 3
Pharmacovigilance and Medical Device Vigilance Workshop
Early Sep, Seoul, Korea 4
Network
Workshops
The AHC Activities
Pharmaceutical Regulatory Framework in APEC The order of average percentage implementation of guideline was Efficacy>Safety> Quality> Multidisciplinary.
The order of education needs was Quality> Efficacy>Safety>Multidisciplinary.
Most people preferred online training and small group workshop.
Conducted 16 countries and received responses from 8 governments and 5 industry.
Investigate to the implementation status of Quality, Efficacy, Safety, Multidisciplinary.
Method
Survey on ICH Guidelines Implementation Status to identify training needs
Object
Online Training
Research
Research – Implementation Status on ICH Guideline
Research – Implementation Status on ICH Guideline
Reported by:
Workshops
The AHC Activities
Online Training
Research
Online Training
Workshop
The AHC Activities
Research
Online Training
Online Training - AHC Workshop Video Clips and Presentation Materials
- APEC RHSC CoE Pilot Videos and Presentation Materials
www.apec-ahc.org
Research - Survey Result Report on the Implementation of ICH guidelines
Workshop
The AHC Activities
Research
Online Training
www.apec-ahc.org E-Learning Center AHC Workshops and CoE Pilot
- Workshop Information - Speakers - Workshop Videos - Presentation Materials
Research Papers
- ICH Guideline Survey Result Report
Network
The AHC cooperates with International organization, regulatory agencies, and industries to enhance the global network to promote regulatory harmonization without having duplication efforts.
Workshop
The AHC Activities
Research
Online Training
Network
How to involve?
www.apec-ahc.org
